Cleared Traditional

AMYLASE (ETHYLIDENE PNGPG7) KIT

K953211 · Randox Laboratories, Ltd. · Chemistry
Jun 1996
Decision
347d
Days
Class 2
Risk

About This 510(k) Submission

K953211 is an FDA 510(k) clearance for the AMYLASE (ETHYLIDENE PNGPG7) KIT, a Saccharogenic, Amylase (Class II — Special Controls, product code CIJ), submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 21, 1996, 347 days after receiving the submission on July 10, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K953211 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1995
Decision Date June 21, 1996
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIJ — Saccharogenic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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